Catalog Number

-

Brand Name

PRS Series

Version/Model Number

PRSJ100A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Public Device Record Key

ebd201b7-afb3-4a95-a992-27f49549e6a0

Public Version Date

April 27, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-